User Manual - Nu

Model No:BA2110
VER: A00
Before Using the Monitor
Introduction................................................................................................1
Symbols Use..............................................................................................2
Important Safety Notes..............................................................................3
Konw Your Unit.......................................................................................4-5
IHB Introduction.........................................................................................6
Before Taking A Measurement...................................................................7
Quick Reference Guide .............................................................................8
Operating Instructions
Battery lnstallation/Replacement...............................................................9
Adjusting Settings....................................................................................10
Proper Use of the Arm Cuff ................................................................11-12
Take a Measurement ..............................................................................13
Use the Memory Function
To read the average value ...................................................................14
To read the measurement value ..........................................................14
To delete the memory value ................................................................15
About Blood Pressure
Blood Circulation ..................................................................................16
Health and Blood Pressure ..................................................................16
Classification of Blood Pressure ..........................................................17
Care and Maintenance
Exceptional Situations
Error Indicators ....................................................................................18
Eliminate Fault .....................................................................................18
Care and Maintenance
Care .....................................................................................................19
Maintenance ........................................................................................19
Specifications ..........................................................................................20
Indications for Use Statement .................................................................21
Statement ................................................................................................21
Warranty Information ..........................................................................22-26
Thank you for purchasing Fully Automatic Upper Arm Style Digital
Blood Pressure Monitor.
The unit uses the oscillometric method of blood pressure
measurement. It means the unit detects the movement of your
blood through your brachial artery, and converts your blood
pressure into a digital reading. The unit is simple to use because a
stethoscope is not needed while using an oscillometric monitor.
The unit stores automatically 60 sets of measurement values. You
can read the stored data conveniently by pressing the memory
button.
The unit comes with the following components:
• Main Unit
• Arm Cuff
• Storage Bag
• Instruction Manual printed in English
Symbols Use
SYMBOLS USED IN THIS INSTRUCTION MANUAL
WARNING
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury to the user or
patient or damage to the equipment or other property.
Type B applied part
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
Refer to instruction manual/booklet
MANUFACTURER
SERIAL NUMBER
The marking of electrical and electronics devices
according to Directive 2002/96/EC.
The device,accessories and the packaging have to be disposed
of waste correctly at the end of the usage.
Please follow Local Ordinances or Regulations for disposal.
2
To assure the correct use of the product basic safety measures
should always be followed including the precautions listed below:
Read all information in the instruction manual and any other
literature included in the box before using the unit.
Contact your physician for specific information about your blood
pressure. Self-diagnosis and treatment using measured results may
be dangerous.Follow the instructions of your healthcare provider.
Operate the unit only as intended. Don't use for any other purpose.
The unit is intended to use in measuring blood pressure and pulse
rate for adult only, not recommended for neonatal baby at home or
medical centre.
Do not use a cellular phone near the unit. It may result in
operational failure.
Please avoid using in high radiant area in order to make your
measuring data correctly.
Do not disassemble or attempt to repair the unit or components.
Do not use the equipment where flammable gas (such as anesthetic
gas, oxygen or hydrogen) or flammable liquid (such as alcohol) are
present.
3
Know Your Unit
Know Your Unit
Body
Display
Air Socket
START/STOP Button
Arm Cuff
Air Plug
Fit for 22cm~32cm
range of upper arm
perimeter
(Insert to Air Socket)
Memory Button
Hose
Metal
Battery Compartment
If your arm cuff is broken or not functional, please use a new cuff.
Voice
A new arm cuff does not include an air plug. Please continue to use the
old air plug on the new arm cuff.
Power
Display
Pouch
4 AA Alkaline Batteries
Systolic Blood Pressure
Low Battery Symbol
Average Value Symbol
Memory & Times
Diastolic Blood Pressure
Unit Indication
Inflation/Deflation Symbol
or WHO Indication
Pulse
Irregular Heartbeat Symbol
Instruction Manual
Please keep the instruction
manual well after using.
Heartbeat Symbol
Warning:
1. Do not use rechargeable batteries.
4
5
IHB Introduction
Irregular Heartbeat Symbol(
)
When the unit detects an irregular rhythm two or more times during
the measurement, the irregular heartbeat Symbol will appear on the
display with the measurement values.
Normal Heartbeat
An irregular heartbeat
rhythm is defined as
a rhythm that varies
by less than 25% from
the average rhythm or
25% more than the
average rhythm
detected while the
monitor is measuring
the systolic and
diastolic blood pressure.
Pulse
Blood
pressure
Irregular Heartbeat
Short Long
Pulse
Blood
pressure
If the Irregular Heartbeat Symbol(
) displays with your
measurement results, we recommend you consult your physician.
Before Taking A Measurement
1.Avoid eating,drinking alcohol, smoking, exercising and bathing for
30 minutes before taking a measurement.
2.Stress raises blood pressure. Avoid taking measurements during
stressful times.
3.The cuff can be applied to your left or right wrist.Always measure
your blood pressure on the same Arm.
4.Measurements should be taken in a quiet place.
5.Position the unit at heart level throughout the measurement.
6.Remain still and do not talk during the measurement.
7.Keep a record of your blood pressure and pulse readings for your
physician.A single measurement does not provide an accurate
indication of your true blood pressure.You need to take and record
several readings over a period of time.Try to measure your blood
pressure at the same time each day for consistency.
8.Wait 30~60 seconds between measurements.
The wait time allows the arteries to return to the condition prior to
taking the blood pressure measurement.You may need to increase
the wait time depending on your individual physiological
characteristics.
Follow the directions of your doctor.
6
7
Remove the battery cover
from the battery
compartment.
Install 4 “AA” size batteries
so the + (positive) and - (negative)
polarities match the polarities
of the battery compartment
as indicated.
+
+
-
+
+
-
Replace the battery cover.
Press the “START/STOP” button.
All symbols appear,then the cuff
starts to inflate automatically.
/
BA2110
8
9
Adjusting Settings
Press the “MEM” button about 10 seconds unil the units (kPa or
mmHg) displayed when the unit turned off.
Then press the “MEM” button again to change the current unit.
Press the “START/STOP” button to save the current setting and
turn off.
Proper Use of the Arm Cuff
sure the air plug is
1 Make
inserted properly in the
main unit.
all clothes from
2 Remove
your upper arm allowing
the cuff to fit directly on
the skin.
in a chair with your
3 Sit
feet flat on the floor.
Place your arm on a
table so as to level the
cuff to your heart.
4 Pass the end of the
cuff through the metal,
and keep the hose
outward.
10
11
Proper Use of the Arm Cuff
5 Put your arm through the
Take a Measurement
1 Press the “START/STOP” button.
loop, then pull it up to the
position of your upper arm.
All display symbols appear on the screen. The cuff starts to
inflate automatically. All symbols display
Deflating automatically
Start to inflate
BA2110
6 The hose runs down the
inside of your arm. The
bottom of the cuff should be
approximately 1~2cm above
your elbow.
1 ~ 2cm
2
Measurement starts while inflating.
The heartbeat symbol flashes once a pulse is detected.
Start to inflate
the cuff tightly around
7 Wrap
your upper arm by using the
Inflating
To a fit pressure
Deflating
Deflating
3 The blood pressure and pulse rate are displayed when
the measurement completed.
Velcro strip. Do not leave
any spacing between the
arm and the cuff.
The cuff is deflated automatically,
and all of the measurement
results are stored in the memory .
The “ ” symbol will be displayed
if irregular heartbeat is detected.
OR
OR
"kPa" display
"mmHg" display
"
4 Press the “START/STOP” button to turn off the unit.
8 Relax your arm, keep the
" display
The unit will anutomatically turn off after 2 minutes if you have
forgotten to turn it off.
palm upward and the
fingers curving naturally,
then turn on the unit and
start to measure.
NOTE: To stop the inflation or measurement,push the “START/STOP”
button,The unit will stop inflating and then release and turn off.
INSTRUCTIONS FOR SPECIAL CONDITIONS
In order to accelerate the measurement time for the systolic pressure more
than 180 mmHg, press and hold the memory button until the unit inflates 30 to
40 mmHg higher than your suspected systolic pressure if you know. ( The unit
will not inflate above 299 mmHg).
12
13
Use the Memory Function
Use the Memory Function
The unit stores the blood pressure and pulse rate in the memory after
completing a measurement every time. It can automatically store 60 sets of
measurement values . The oldest record is deleted to save the latest
measurement value when more than 60 sets.
The unit also calculates an average reading based on the values of the latest
3 times measurement taken.
To read the average value
Press the “MEM” button. The average value symbol will
display.
To delete the memory value .........................................
In the memory reading mode, press the “MEM” button for 4-6 seconds,
the unit will display “
”.
Press the “MEM” button again and confirm to select “ ” or
“ ”.
If you are sure all the data of corresponding user can be deleted, press
the “START/STOP” button, all the corresponding user’s data will be
deleted and the unit will turn off.
Turn to next
the average value of
all measurent values
TO read the measurement value .............................................
Press the “MEM” button to view the latest measurement value.
The 2nd latest
measurement value
The 1st latest
measurement value
14
Note: if you have set “
”, but do not press a button for 2 minutes,
the product will shut off automatically, but the corresponding user’s
blood pressure data will not be deleted. The delete operation must
be confirmed by user.
The 60th latest
measurement value
15
About Blood Pressure
About Blood Pressure
Blood Circulation
Classification of Blood Pressure
The blood circulation is responsible for supplying the body with oxygen.
Blood pressure is the pressure exerted on the arteries.
After each measurement is completed, the LCD display will show your
position automatically on the six segments of the bar indicator which
corresponds to World Health Organization (WHO) Blood Pressure Indicator.
The systolic blood pressure value (higher pressure or top value) represents
the blood pressure produced by contraction of the heart muscle.
The diastolic blood pressure value (lower pressure or lower value) represents
the blood pressure produced by relaxation of the heart muscle.
Systolic Blood Pressure
Diastolic Blood Pressure
Reference Material: Journal of Hypertension 1999, Vol 17 No.2
Diastolic Blood Pressur (mmHg)
Severe hypertension
110
WHO
Moderate hypertension
100
Red
Mild hypertension
Contraction of
the heart muscle
Relaxation of the
heart muscle
Extrude blood
Blood return heart
Pressure increased
to the blood vessel
Pressure decreased
to the blood vessel
Higher pressure
Lower pressure
90
Normal systolic value
Yellow
85
Green
Normal blood pressure
80
Optimal
blood pressure
(target value)
120
130
140
160
180
Systolic Blood Pressure (mmHg)
*Note!
When a person’s systolic and diastolic pressures fall into different categories,
the higher category should apply.
Classification of Blood Pressure
16
17
Exceptional Situations
Care
The following symbol will appear on the display when measuring abnormally.
Cause
Correction
Wrap the cuff correctly and tightly.
The course of
inflating appears
error.
Ensure the connection is close
between the air plug and the unit.
Inflate over again after ensuring.
When measurement
fails.
When the batteries
power are too low.
Do not move your arm and body,
and keep quiet.
Measure over again according to
correct way.
Replace all of the worn batteries
with new ones.
Keep the unit in the storage case
when not in use.
Clean the unit with a soft dry cloth.
Do not use any abrasive or volatile
cleaners.
Never immerse the unit or any
components in water.
※ If needed, please use ultraviolet radiation for disinfection.
Avoid subjecting the monitor to strong shocks or vibrations,
such as dropping the unit on the floor.
Maintenance
Do not wet the cuff or attempt to
clean the cuff with water.
Do not clean the body and cuff with
naphtha, thinner or gasoline etc.
naphtha
Error Indicators
Symbol
Care and Maintenance
thinner
gasoline
Eliminate Fault
Problem
Causes and Solutions
No power.
Replace all the worn batteries with 4 new
ones.
No display appears on the
display screen.
Check the battery installation for proper
placement of the batteries polarities.
Measurement values
appear too high or too low.
Blood pressure varies constantly. Many
factors including stress, time of day, how
you wrap the cuff, may affect your blood
pressure. Review the sections "Proper Use
of the Arm Cuff" and "Take a Measurement".
Store the unit in a clean and dry
location. Do not subject the unit to
extreme hot or cold temperature,
humidity and direct sunlight.
Remove the batteries if the unit will
not be used for 3 months or longer.
Always replace all of the batteries
with new ones at the same time.
18
+
+
-
+
+
-
Use the unit consistent with the instructions provided in this manual.
Use only authorized parts and accessories.
19
Indications for Use Statement
The unit is intended to be used to measure blood pressure
(systolic and diastolic) and heart rate from the upper arm by using
the oscillometric method.
BA2110
The unit is intended for usingin only adult population,not applied
to the other populations such as neonatal baby.
It can’t be used while the wirst (arm) has bleeding or wound to
avoid the blood flowing from the wound in pressurzing.
180
The unit satisfies the requirements of IEC60601-1 Medical electrical
equipment, EN1060-1: Non-invasive sphygmomanometer,
EN1060-3: Non-invasive sphygmomanometer.
The Unit complies with IEC 80601-2-30.
60 Sets of Measurement Values
4 AA Alkaline Batteries
Automatic Turn Off
Dimensions
Within 2 Minutes
Approx. 145*145*64mm
Approx. 420g (Batteries not included)
10~40℃ (50 ~ 104 F )
15 ~ 90% RH ( Noncondensing)
80~105 kPa
-20~60℃ (-4 ~ 140 F )
10 ~ 95% RH ( Noncondensing)
20
21
Warranty Information
Warranty Information
Federal law restricts this device to sale by or on the order of a physician.
requirements; EN1060-3: Non-invasive sphygmomanometers – Part 3:
The unit, excluding the unit cuff, is guaranteed to be free of defects in
workmanship and materials for a period of two years from the date listed
on the purchase record. when used in accordance with the instructions
provided with the unit. The unit cuff is warranted to be free from detects in
materials and workmanship appearing within one year from the date listed
on the purchase record when the unit is used in accordance with the
instructions provided with the unit.
Supplementary requirements for electro-mechanical blood pressure
For repair under this warranty. Our authorized service agent must be
advised of the fault within the period of the warranty. This warranty covers
parts and labor only under normal operations. A transportation fee or
freight fee that may be incurred will be the owner's responsibility. Any
defect resulting from natural causes, e.g., flood, hurricane etc., is not within
this guarantee. This guaranty does not cover damage incurred by: use of
the unit not in accordance with the instructions, accidental damage, or
being tampered with or serviced by unauthorized service agents.
Unit subjected to misuse, abuse, and neglect of these manual content,
non-instructional purposes; unauthorized repair or modifications will be
excluded from this warranty. This guarantee specifically excludes
expendables and consumables, for example batteries. All warranty claims
must be directed to the distributor responsible for the sale of the device.
The content of this warranty is subject to change without further notice.
Periodical check:
Sensitive measuring devices must be checked from time to time for
accuracy and leakage, we therefore recommend that the performance
should be checked every 2 years.
Check and maintenance and repair for the unit, please contact the local
distributor for details.
Clean the cuff with a soft dry cloth.
The unit satisfies the requirements of EN60601-1：Medical electrical
equipment Part 1: General requirements for basic safety and essential
performance; EN60601-1-2: Medical electrical equipment Part 1-2:
General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and
tests; EN1060-1: Non-invasive sphygmomanometers – Part 1: General
22
measuring system. EN1060-4：Non-invasive sphygmomanometers –
Part 4: Test procedures to determine the overall system accuracy of
automated non-invasive sphygmomanometers.
Warning: Do not use Luer lock connector in the construction tubing, There
is a possibility that they might be inadvertently connected to intravascular
fluid systems, allowing air to be pumped into a blood vessel.
It can’t be used while the wrist (arm) has bleeding or wound to avoid the
blood flowing from the wound in pressurizing.
Applied parts contains cuff.
The device，accessories and the packaging have to be disposed of waste
correctly at the end of the usage. Please follow Local Ordinances or
Regulations for disposal.
Protection Class: Internally powered equipment
Applied Part Type: Type B
Moisture Protection: IPX0, continue operation
WARNING: No modification of this equipment is allowed.
Manufacturer will make available on request circuit diagrams, component
part lists etc for the service personnel in parts repair.
Caution: this machine should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, this machine
should be observed to verify normal operation in the configuration in which
it will be used.
*MEDICAL ELECTRICAL EQUIPMENT needs special precautions
regarding EMC and needs to be installed and put into service according to
the EMC information provided in the ACCOMPANYING DOCUMENTS.
*Portable and mobile RF communications equipment can affect MEDICAL
ELECTRICAL EQUIPMENT.
* Do not use a mobile phone or other devices that emit electromagnetic
fields, near the unit. This may result in incorrect operation of the unit.
23
Warranty Information
Caution: This unit has been thoroughly tested and inspected to assure
proper performance and operation!
WARNING:
The use of ACCESSORIES, transducers and cables other than those
specified, with the exception of transducers and cables sold by the
MANUFACTURER of the COMPRESSOR NEBULIZER as replacement
parts for internal components, may result in increased EMISSIONS or
decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.
Guidance and manufacture’s declaration
Guidance and manufacture’s declaration – electromagnetic emission
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment
specified below. The customer of the user of the Digital Blood Pressure Monitor should
assure that it is used in such an environment.
Emission test
Compliance
RF emissions
CISPR 11
Group 1
RF emission
CISPR 11
Class B
Electromagnetic environment – guidance
The Digital Blood Pressure Monitor use RF energy only for
its internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
Harmonic
The Digital Blood Pressure Monitor is suitable for use in all
emissions
Not applicable establishments other than domestic and those directly
IEC 61000-3-2
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Voltage
fluctuations/ Not applicable
flicker emissions
IEC 61000-3-3
Warranty Information
Guidance and manufacture’s declaration – electromagnetic immunity
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of Digital Blood Pressure Monitor should assure
that it is used in such an environment.
Immunity test
IEC 60601 test
level
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
Power frequency
(50Hz/60Hz)
magnetic field IEC
61000-4-8
3A/m
Compliance
level
Electromagnetic environment - guidance
Floors should be wood, concrete or
±6 kV contact ceramic tile. If floor are covered with
±8 kV air
synthetic material, the relative humidity
should be at least 30%.
3A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacture’s declaration – electromagnetic immunity
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of Digital Blood Pressure Monitor should assure
that it is used in such an environment.
Immunity test
Radiated RF
IEC 61000-4-3
IEC 60601 test Compliance
level
level
3A/m
80 MHz to 2.5
GHz
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the Digital Blood Pressure Monitor,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
3A/m
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
24
25
Warranty Information
Immunity test
Radiated RF
IEC 61000-4-3
IEC 60601 test Compliance
level
level
3A/m
80 MHz to 2.5
GHz
Electromagnetic environment - guidance
survey,a should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
3A/m
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Digital Blood Pressure
Monitor is used exceeds the applicable RF compliance level above, the Digital Blood
Pressure Monitor should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the
Digital Blood Pressure Monitor.
Recommended separation distances between
portable and mobile RF communications equipment and the Digital Blood Pressure Monitor.
Pressure Monitor is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the Digital Blood Pressure
Monitor can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the Digital
Blood Pressure Monitor as recommended below, according to the maximum output power
of the communications equipment.
Separation distance
according to frequency of transmitter
(m)
output power
of transmitter
80 MHz to 800 MHz
80 MHz to 800 MHz
0.01
0.1
1
10
0.117
0.369
1.167
3.689
0.233
0.738
2.333
7.379
100
11.667
23.333
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
26

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